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Enteric-coated mycophenolate sodium versus mycophenolate mofetil in renal transplant recipients experiencing
Anthony J Langone1, Laurence Chan, Paul Bolin
1Division of Nephrology, Vanderbilt University Medical Center, Nashville, TN, USA. anthony.langone@vanderbilt.edu
Background:
Two open-label studies demonstrated that conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) significantly reduces gastrointestinal (GI) symptom burden and improves GI-specific health-related quality of life. Using a randomized design, this study evaluated changes in GI symptoms and health-related quality of life in patients converted from MMF to EC-MPS versus patients who continued with MMF-based treatment.
Methods:
In this 4-week, multicenter, randomized, prospective, double-blind, parallel-group trial, renal transplant recipients with GI symptoms receiving MMF plus a calcineurin inhibitor ± corticosteroids were randomized to an equimolar dose of EC-MPS+MMF placebo or continue on their MMF-based regimen+EC-MPS placebo. The primary efficacy outcome was a change from baseline in total Gastrointestinal Symptom Rating Scale score of a minimally important difference of more than or equal to 0.3.
Results:
Three hundred ninety-six patients (EC-MPS group: n=199; MMF group: n=197) were included. A greater proportion of EC-MPS patients (62%) reached the primary efficacy outcome compared with MMF patients (55%); however, the difference was not statistically significant (P=0.15). EC-MPS patients had a significantly greater decrease in the Gastrointestinal Symptom Rating Scale indigestion syndrome dimension versus MMF patients. Within the subgroups of patients with diabetes, patients transplanted 6 to 12 months of study enrollment, and patients on steroids, a statistically significant greater proportion of EC-MPS versus MMF patients reached the primary efficacy outcome.
Conclusions:
Conversion from MMF to EC-MPS may be associated with improvements in presence and severity of GI symptoms, particularly in patients with indigestion, diabetes, on steroids, and in patients converted between 6 and 12 months posttransplantation.
Insights
Converting from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) may improve gastrointestinal symptoms. This benefit was particularly noted in specific patient subgroups, including those with indigestion, diabetes, or on steroids.
Area of Science:
- Nephrology
- Immunosuppression
- Gastroenterology
Background:
- Previous studies indicated that switching from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) reduces gastrointestinal (GI) symptoms.
- This randomized trial aimed to confirm these findings by comparing EC-MPS conversion to continued MMF treatment in renal transplant recipients with GI issues.
Purpose of the Study:
- To evaluate the efficacy of converting from MMF to EC-MPS in improving GI symptoms and health-related quality of life.
- To compare EC-MPS treatment against continued MMF treatment in a randomized, double-blind trial.
Main Methods:
- A 4-week, multicenter, randomized, double-blind, parallel-group trial involved 396 renal transplant recipients experiencing GI symptoms.
- Patients were randomized to receive either equimolar EC-MPS or continue their MMF regimen.
- The primary outcome was the change in total Gastrointestinal Symptom Rating Scale (GSRS) score, aiming for a minimally important difference of ≥0.3.
Main Results:
- While 62% of EC-MPS patients achieved the primary outcome versus 55% of MMF patients, the difference was not statistically significant (P=0.15).
- EC-MPS treatment led to a significant reduction in the GSRS indigestion syndrome dimension compared to MMF.
- Subgroup analyses revealed statistically significant improvements in the primary outcome for EC-MPS patients with diabetes, those on steroids, and those transplanted 6-12 months prior.
Conclusions:
- Conversion from MMF to EC-MPS may improve the presence and severity of GI symptoms, especially in patients with indigestion.
- Specific patient groups, including those with diabetes, on steroids, and within 6-12 months post-transplant, showed a statistically significant benefit from EC-MPS conversion.
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